Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas

NCT ID: NCT06311032

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-29

Study Completion Date

2023-07-28

Brief Summary

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The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.

Detailed Description

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The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.

This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.

Conditions

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Surgery Risk Assessment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vignettes with Risk Stratification Tool

Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be provided a risk stratification tool (DART-1) when presented with their clinical case vignettes.

The DART-1 is a 5-question tool which calculates the probability (%) of IPMNs without worrisome features or high-risk stigmata at diagnosis.

No interventions assigned to this group

Vignettes without Risk Stratification Tool

Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be not be provided a risk stratification tool when presented with their clinical case vignettes.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Membership in either the PACYFIC or PRECEDE consortiums
* Physician with expertise in the management of IPMN
* Able and willing to complete survey

Exclusion Criteria

* Not a member of either the PACYFIC or PRECEDE consortiums
* Not a physician with expertise in the management of IPMN
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greg Sacks, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-01227

Identifier Type: -

Identifier Source: org_study_id

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